TRIGEN 71675515Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556344446), received between Sep 10, 2021 and Jun 13, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (1 report).

6 other recalls cover devices cleared under the same FDA submission (K040212, K241804); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 13, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PAIN. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) INTERTAN 10S 10MM X 40CM 125D LEFT AND ONE (1) LAG/COMP SCREW KIT 90/85 WERE REMOVED, AS THE PATIENT¿S ANATOMY REQUIRED A NECK ANGLE GREATER THAN 125 DEGREES. THESE WERE REPLACED WITH A COMPETITOR DEVICE. THE BACK-UP DEVICE WAS IMPLANTED INTO THE ORIGINALLY DRILLED BONE HOLE. CURRENT HEALTH STATUS OF PATIENT REMAINS UNKNOWN.

  Patient problems: Pain

  MAUDE report 22203122 ↗
• InjuryDec 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING A LEFT IMN FIXATION SURGERY PERFORMED ON (B)(6) 2016 TO TREAT A DISPLACED INTERTROCHANTERIC FRACTURE OF THE FEMUR, THE PATIENT SUSTAINED MALUNION OF THE FRACTURE LINE AND REQUIRED A CONVERSION TO THR ON (B)(6) 2016. THIS INFORMATION WAS COLLECTED RETROSPECTIVELY AS PART OF A POST-MARKET CLINICAL FOLLOW UP (PMCF) ACTIVITY AND IS PROVIDED IN AN ANONYMIZED FORMAT; THEREFORE, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Malunion of Bone

  MAUDE report 20896290 ↗
• InjurySep 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION PROCEDURE HAD BEEN PERFORMED ON THE PATIENT'S LEFT FEMUR ON (B)(6) 2019 TO TREAT AN INTERTROCHANTERIC FRACTURE, THE PATIENT SUSTAINED A NEW PERIPROSTHETIC STRESS FRACTURE. ALTHOUGH THE SPECIFIC AREA IN WHICH THIS FRACTURE DEVELOPED WAS NOT PROVIDED, THE PATIENT UNDERWENT UNPLANNED REMOVAL OF THE HARDWARE ON (B)(6) 2019. ADDITIONAL DETAILS REGARDING THE CLINICAL COURSE OF THE PATIENT WERE NOT PROVIDED. THIS INCIDENT WAS NOTICED IN A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF)], ADDITIONAL INFORMATION IS NOT KNOWN, AND IT IS NOT POSSIBLE TO COLLECT IT, WE DO NOT HAVE THE OPPORTUNITY TO REVISIT NEGATIVE FEEDBACK TO RETRIEVE FURTHER INFORMATION.

  Patient problems: Bone Fracture(s); Fall; Implant Pain

  MAUDE report 15459778 ↗
• InjurySep 10, 2021Break; Break

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY ON (B)(6) 2021, A INTERTAN 10S 10MM X 40CM 125D LEFT AND A INTERTAN LAG/ COMPRESSION SCREW KIT 95MM / 90MM BROKE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO REMOVE IT AND INSERT A NEW ONE. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 12453351 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040212, K241804. One submission often covers many models, so check the product and lot details in each record.

• Z-1133-2022 · Apr 22, 2022 · Open, Classified
  INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Right
• Z-0772-2021 · Nov 2, 2020 · Terminated
  Bone fixation nail. TRIGEN INTERTAN - Product Usage: indicated for fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long
• Z-0097-2018 · Oct 24, 2017 · Open, Classified
  smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN NAIL
• Z-2258-2014 · Jul 2, 2014 · Terminated
  TRIGEN(R) INTERTAN(TM) 10MM X 18 CM NAIL, 125o, REF 71675201, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 18 CM NAIL, 125o, REF 71
• Z-1637-2014 · Apr 4, 2014 · Terminated
  TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT, (2) REF 71676556, 11.5 MM X 36 CM, 125 degree, RIGHT, (3) REF 71676558, 11.5 MM X 38 CM, 125 degree
• Z-1636-2014 · Apr 4, 2014 · Terminated
  TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) REF 71675202, 11.5 MM X 18 CM, 125 degree, (3) REF 71675203, 13 MM X 18 CM, 125 degree, (4) REF 71675204,